Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-02-01

Brief Summary

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Lumbar spinal stenosis with neurogenic claudication is a common condition in the elderly population and is characterized by bilateral buttock, thigh, or calf discomfort and/or pain, as well as by weakness precipitated by walking and prolonged standing. Self-management options include physical therapy, which includes exercise as a core component for improving the flexibility and mobility of the spine and hips. A Williams flexion protocol has historically been used to treat low-back pain following degenerative changes to the posterior elements of the lumbar spine. However, few studies have been done to validate the efficacy of this protocol. A more focused treatment protocol may be more efficacious. Patients in this study will be randomized to receive either the generic physical therapy protocol (15 sessions) or the focused rehabilitation program (5 sessions). The sessions will take place over the course of 6 months. Outcomes will be assessed using validated questionnaires and physical function tests.

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Detailed Description

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Conditions

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Spinal Stenosis Lumbar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard

Group Type ACTIVE_COMPARATOR

Williams flexion protocol

Intervention Type PROCEDURE

The Williams flexion protocol group will participate in 15 treatment sessions.

Individualized

Group Type EXPERIMENTAL

Focused spinal stenosis rehabilitation

Intervention Type PROCEDURE

The focused spinal stenosis rehabilitation group will participate in 5 treatment sessions.

Interventions

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Williams flexion protocol

The Williams flexion protocol group will participate in 15 treatment sessions.

Intervention Type PROCEDURE

Focused spinal stenosis rehabilitation

The focused spinal stenosis rehabilitation group will participate in 5 treatment sessions.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Lumbar spinal stenosis with neurogenic claudication
* Symptoms present for at least 3 months
* Moderate to severe acquired or congenital LSS based on radiological evaluation
* Lumbar MRI obtained within the past 12 months prior to initial physical therapy visit
* 40 years of age or older
* Body mass index less than or equal to 35
* Can tolerate a 6-min treadmill test
* Willing to comply with home exercises as prescribed

Exclusion Criteria

* Acute disc herniation
* Grade 3 or greater spondylolisthesis
* Rheumatoid or autoimmune conditions (e.g., ankylosing spondylitis)
* Active spinal compression fractures
* Knee surgery in the previous 6 months (e.g., total knee arthroplasty)
* Previous spinal fusion
* Absence of pedal pulses
* Inflammation/infectious process
* Myelopathy
* Psychiatric disorder preventing informed consent or participation in assigned physical therapy sessions
* Patients with pending litigation or workers compensation

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No